Centro Sperimentale del Latte submitted an article 14 claim for children between 3 months and 14 years that stated a combination of Lactobacillus delbrueckii subsp.bulgaricus AY/CSL (LMG P-17224) and Streptococcus thermophilus 9Y/CSL (LMG P-17225) could have a “beneficial modulation of the intestinal microflora".
Aside form the non-characterisation problem, the NDA said the company failed to respond to its questions demanding further information about the claim, and affirmed its controversial position on gut microflora.
“Increasing the number of any group of microorganisms, including lactobacilli and/or bifidobacteria, is not considered in itself a beneficial physiological effect,” it wrote.
“Thus the applicant was requested to provide the rationale regarding the extent to which the claimed effect is a beneficial physiological effect. No reply was received from the applicant to the Panel’s request for supplementary information.”
“The Panel considers that no evidence has been provided by the applicant to establish that the claimed effect, “beneficial modulation of the intestinal microflora", is a beneficial physiological effect.”
Centro Sperimentale del Latte was not available for comment at the time of publication.
The opinion can be found here.